MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD® CADD-LEGACY® PCA PUMP; PUMP, INFUSION, ENTERAL

Model Number 1400

Device Problem Corroded (1131)

Patient Problem No Patient Involvement (2645)

Event Date 08/24/2017

Event Type  malfunction  

Event Description

A cadd® cadd-legacy® pca pump was sent to smiths-medical for repair of a corroded battery compartment.

Manufacturer Narrative

One pump was returned for evaluation.Visual inspection found the device in fair condition with evidence of fluid exposure on all pump surfaces.It was observed that there was corrosion in the battery department.It was suspected that the corrosion was due to patient medication.A review of the event log found no errors.Functional testing involved simulated use testing, delivery accuracy testing, and sensor testing found no discrepancies.Based on the evidence, the root cause was attributed to fluid ingression due to a user issue.

• Brand Name: CADD® CADD-LEGACY® PCA PUMP
• Type of Device: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 1265 gray fox road; st. paul MN 55112
• Manufacturer Contact: dave halverson ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833310
• MDR Report Key: 6849510
• MDR Text Key: 85160345
• Report Number: 3012307300-2017-01999
• Device Sequence Number: 1
• Product Code: LZH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N203952
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 1400
• Device Catalogue Number: 21-1401-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/11/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1